Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GELS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITOR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PULSE GENERATOR

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR INSYNC ICD, MODEL 7272 AND INSYNC MARQUIS, M

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM